PMA · Approved
ApprovedGore Helex Septal Occluder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · MLV Transcatheter Septal Occluder
Approved on Aug 11, 2006 through premarket approval, which rests on the device’s own clinical evidence after a 528-day review.
- Decided
- Aug 11, 2006
- Review
- 528 days
- Class
- Class III
- Product code
- MLV
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P050006 has 114 supplements since 2006: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2006 | 1 |
| 2007 | 3 |
| 2008 | 4 |
| 2009 | 6 |
| 2010 | 2 |
| 2011 | 10 |
| 2012 | 7 |
| 2013 | 4 |
| 2014 | 6 |
| 2015 | 5 |
| 2016 | 7 |
| 2017 | 4 |
| 2018 | 9 |
| 2019 | 10 |
| 2020 | 6 |
| 2021 | 8 |
| 2022 | 8 |
| 2023 | 2 |
| 2024 | 6 |
| 2025 | 3 |
| 2026 | 3 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MLV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MLV devicesMLV Transcatheter Septal Occluder: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MLV
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLV
Too few MLV 510(k)s in any year since 2007 to give a median.
Recalls per year · MLV
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLV
766in 2025
MAUDE reports naming product code MLV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | — | 0 | 103 |
| 2008 | 9 | — | 0 | 178 |
| 2009 | 11 | — | 0 | 187 |
| 2010 | 6 | — | 0 | 186 |
| 2011 | 13 | — | 0 | 201 |
| 2012 | 9 | — | 0 | 189 |
| 2013 | 5 | — | 0 | 134 |
| 2014 | 7 | — | 0 | 103 |
| 2015 | 5 | — | 0 | 133 |
| 2016 | 17 | — | 0 | 123 |
| 2017 | 13 | — | 0 | 140 |
| 2018 | 14 | — | 0 | 212 |
| 2019 | 27 | — | 0 | 406 |
| 2020 | 21 | — | 0 | 407 |
| 2021 | 14 | — | 9 | 487 |
| 2022 | 11 | — | 2 | 504 |
| 2023 | 3 | — | 0 | 672 |
| 2024 | 16 | — | 0 | 843 |
| 2025 | 8 | — | 0 | 766 |
| 2026 | 6 | — | 0 | — |
https://510kreport.com/device/P050006 · printed Nov 6, 2026
Cite this page
510(k) Report. “P050006: Gore Helex Septal Occluder.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P050006
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026